The FDA has approved cemiplimab-rwlc (Libtayo) as a new treatment option to help prevent cutaneous squamous cell carcinoma (CSCC) from returning after surgery and radiation. This approval brings hope to adults with CSCC who are at high risk of the cancer coming back, offering another way to lower the chances of recurrence.
Who Can Benefit?
This new approval is intended for patients who have completed surgery and radiation for CSCC and are considered at high risk for relapse. Patients usually start cemiplimab-rwlc within 2 to 10 weeks after finishing radiation.
What Did the Research Show?
In a clinical study with 415 participants, those who received cemiplimab-rwlc after their standard treatments had a longer period without the cancer returning compared to those who did not receive the drug (placebo group). The main goal of the study was to look at disease-free survival—meaning the time during which patients stayed cancer-free after treatment.
- In the group taking cemiplimab-rwlc, the median time before cancer returned was not reached, meaning many patients were still cancer-free at the end of the study.
- In the placebo group, median disease-free survival was nearly 49.4 months.
- The risk of cancer recurrence or death was about 68% lower with cemiplimab-rwlc compared to placebo (Hazard Ratio 0.32, p < 0.0001).
Safety Information
While cemiplimab-rwlc offers new hope, it can also cause side effects. Some patients may experience immune system-related reactions, infusion reactions, or other serious complications, including risks for pregnant patients. It is important to discuss these a potential side effects with your healthcare team before starting treatment.
About Libtayo
Libtayo is a fully human monoclonal antibody precision medicine know as a “checkpoint inhibitor”. Libtayo targets the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo block cancer cells from using the PD-1 pathway to suppress T-cell activation.
Approved indications for Libtayo
- High-risk CSCC: Adjuvant treatment after surgery and radiation (most recent approval)
- Advanced CSCC: Treatment for advanced cutaneous squamous cell carcinoma
- Advanced BCC: Treatment for advanced basal cell carcinoma
- NSCLC:
- First-line treatment for patients with advanced NSCLC whose tumors express high PD-L1
- Combination with platinum-based chemotherapy for advanced NSCLC
- Advanced cervical cancer: Treatment for advanced cervical cancer
This approval represents a step forward for patients facing high-risk CSCC, expanding the options available for preventing recurrence after initial therapies.
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